{"id":"hpv-16-18-l1-vlp-as04","safety":{"commonSideEffects":[{"rate":"60-70","effect":"Injection site pain"},{"rate":"20-30","effect":"Injection site redness"},{"rate":"20-30","effect":"Injection site swelling"},{"rate":"10-20","effect":"Fatigue"},{"rate":"10-20","effect":"Myalgia"},{"rate":"10-20","effect":"Headache"},{"rate":"5-10","effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HPV-16/18 L1 VLP AS04 is a prophylactic vaccine containing virus-like particles (VLPs) derived from the major capsid protein (L1) of human papillomavirus types 16 and 18, formulated with the AS04 adjuvant system to enhance immunogenicity. The vaccine triggers both humoral and cellular immune responses that generate neutralizing antibodies against HPV-16 and HPV-18, the two high-risk HPV types responsible for approximately 70% of cervical cancers. By preventing initial infection with these oncogenic HPV types, the vaccine reduces the risk of cervical intraepithelial neoplasia and cervical cancer development.","oneSentence":"This vaccine stimulates the immune system to produce antibodies against HPV-16 and HPV-18 virus-like particles, preventing infection and cervical cancer development.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:45:31.084Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical cancer caused by HPV-16 and HPV-18"},{"name":"Prevention of cervical intraepithelial neoplasia (CIN) caused by HPV-16 and HPV-18"}]},"trialDetails":[{"nctId":"NCT05237947","phase":"PHASE4","title":"Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-03-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":5000},{"nctId":"NCT03180034","phase":"PHASE4","title":"Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-11-29","conditions":"Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma","enrollment":27945},{"nctId":"NCT03728881","phase":"PHASE3","title":"Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2019-04-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":1240},{"nctId":"NCT03438006","phase":"","title":"A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-05-31","conditions":"Cervical Intraepithelial Neoplasia","enrollment":3016},{"nctId":"NCT03105856","phase":"PHASE4","title":"FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program","status":"COMPLETED","sponsor":"Instituto Nacional de Salud Publica, Mexico","startDate":"2017-01-03","conditions":"Cervical Intraepithelial Neoplasia, HPV-Related Cervical Carcinoma","enrollment":3000},{"nctId":"NCT01627561","phase":"PHASE3","title":"Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-10-15","conditions":"Infections, Papillomavirus","enrollment":148},{"nctId":"NCT00423046","phase":"PHASE3","title":"Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01-24","conditions":"Infections, Papillomavirus, Papillomavirus Vaccines","enrollment":1106},{"nctId":"NCT00730847","phase":"PHASE4","title":"A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2008-09-17","conditions":"Human Papillomavirus Infection Leading to Cervical Cancer","enrollment":743},{"nctId":"NCT00128661","phase":"PHASE3","title":"Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-06-30","conditions":"Cervical Cancer, Precancerous Condition","enrollment":7466},{"nctId":"NCT00309166","phase":"PHASE2","title":"Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04-05","conditions":"Infections, Papillomavirus","enrollment":270},{"nctId":"NCT00316693","phase":"PHASE2","title":"Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04-26","conditions":"Infections, Papillomavirus","enrollment":1046},{"nctId":"NCT00492544","phase":"PHASE3","title":"Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-07-02","conditions":"Infections, Papillomavirus","enrollment":100},{"nctId":"NCT00122681","phase":"PHASE3","title":"Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-05-06","conditions":"Infections, Papillomavirus","enrollment":18729},{"nctId":"NCT00549900","phase":"PHASE1","title":"A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-12-02","conditions":"Infections, Papillomavirus","enrollment":30},{"nctId":"NCT00345878","phase":"PHASE3","title":"Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-25","conditions":"Infections, Papillomavirus","enrollment":271},{"nctId":"NCT00485732","phase":"PHASE3","title":"A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-06-11","conditions":"Infections, Papillomavirus","enrollment":225},{"nctId":"NCT00344032","phase":"PHASE3","title":"Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-07-28","conditions":"Infections, Papillomavirus","enrollment":354},{"nctId":"NCT00306241","phase":"PHASE3","title":"A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-03","conditions":"Infections, Papillomavirus","enrollment":300},{"nctId":"NCT02100618","phase":"PHASE3","title":"Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2015-01","conditions":"Infections, Papillomavirus","enrollment":""},{"nctId":"NCT00572000","phase":"NA","title":"Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule","status":"UNKNOWN","sponsor":"National Institute for Control of Vaccine and Biologicals","startDate":"2007-11","conditions":"Human Papillomavirus (HPV) Vaccine","enrollment":222}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"HPV-16/18 L1 VLP AS04","genericName":"HPV-16/18 L1 VLP AS04","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This vaccine stimulates the immune system to produce antibodies against HPV-16 and HPV-18 virus-like particles, preventing infection and cervical cancer development. Used for Prevention of cervical cancer caused by HPV-16 and HPV-18, Prevention of cervical intraepithelial neoplasia (CIN) caused by HPV-16 and HPV-18.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}